A Phase 2 interventional study of BMS-690514 and Erlotinib in Non Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Completed at 30 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 141 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BMS-690514
Drug: Erlotinib
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
Also known as: panHER
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Also known as: Tarceva
To compare the progression-free survival of patients on BMS-690514 with those on erlotinib
Time frame: CT/MRI at baseline and every 6 weeks for 36 weeks
To compare the overall survival between BMS-690514 and erlotinib
Time frame: 15 months
To estimate the overall response rate of BMS-690514 or erlotinib
Time frame: 15 months
To estimate the tumor size change and PFS rate at 6 weeks
Time frame: 6 weeks
To assess safety and tolerability of BMS-690514 and erlotinib
Time frame: 15 months
To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib
Time frame: 15 months
To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients
Time frame: Days 1,8,15, 29
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Bristol-Myers Squibb